Provodine Testing, Trials and Studies
The FDA regulates the sales and marketing of OTC drugs with the CFR’s OTC Drug Monograph system. Provodine®, a Professional Healthcare Antiseptic, meets or exceeds the requirements of the Monograph (identity of the active ingredient, concentration of the ingredient, etc.), and features a GRASE (generally recognized as safe and effective) active ingredient, Povidone-Iodine. Once a product meets the requirements in the CFR, the product is approved for sale in the US.
Microdermis has put Provodine through demanding, in-vitro laboratory testing. These tests include studies directed to the most devastating organisms, including multi drug resistant organisms and an assortment of microbes of concern.
Setting a New Standard of Excellence
It is uncommon for OTC drugs to be submitted to the type of rigorous studies Microdermis is pursuing with Provodine. Today, Provodine already meets the current FDA standard for OTC Professional Antiseptics. With an eye to the future, Microdermis is setting a new standard by initiating and implementing a series of rigorous clinical trials with noted medical institutions across the country.
Microdermis is pursuing a clinical trials plan focusing on the major universities and top teaching hospitals, the Military, and VA Hospitals. Microdermis continues to demonstrate its HAI-reduction efficacy by studying the economic impact of Provodine via large-scale, system-wide savings attributable to the decline in HAI rates due to implementation of Provodine. Clinical studies also examine the correlation between increased compliance with hand hygiene protocols and decreased absenteeism of staff after implementation of Provodine use.
Studies have demonstrated the highly effective killing activity of Provodine against the vegetative state of C. difficile and its ability to remove spores from the skin. Future studies will further characterize its activity against C. diff and other microbes. Other clinical trials will also evaluate Provodine’s efficacy and safety in a wide range of clinical settings and uses.
The current emerging body of data all support the market-disrupting performance of Provodine—attributable in part to Microdermis’ patented Amidermal® delivery technology. Please review our index of research reports and white papers (available upon request) to learn how Provodine can make a real difference in the lives of patients and healthcare workers in your institution.
Provodine Lab Studies
|First Aid Antiseptic Time Kill Study||BioScience Laboratories, Inc.||2014||On average Provodine exhibited greater than a 6 log reduction on the 3 required species.|
|In-Vitro: Minimum Inhibitory Concentrations (MICs)||Antimicrobial Test Laboratories||2014||Provodine exerts inhibitory activity over microorganisms at low concentrations, ranging from 0.048% to 6.25%|
|In-Vitro: Time Kill Spectrum Study||Antimicrobial Test Laboratories||2014||Provodine exhibits reduction of bacterial counts of 4-5 logs under 60 seconds|
|In-Vitro Time Kill: Serratia marcescens, MRSA and Acinetobacter baumanii||Gibraltar Laboratories, Inc.||2012||Provodine demonstrated an immediate and significant microbial kill in bacteria tested.|
|In-Vitro: Antiviral Properties (Influenza A: H1N1)||BioScience Laboratories, Inc.||2009||Provodine showed a 99.99% reduction in the infectivity of a Influenza A (H1N1) virus strain following 30 second exposures.|
|In-Vitro: Antiviral Properties II||Antimicrobial Test Laboratories||2013||Provodine showed a viral reduction of 4.88 logs in under 30 seconds against H1N1, (Influenza A), 3.75 logs in under 30 seconds against Human Coronovirus 229E (MERS Surrogate), and 3.9 log reduction in under 30 seconds against Feline Calicavirus (F-9), which has been approved for use by the FDA and EPA as a surrogate for Human Norovirus.|
Provodine Clinical Summaries
|Antimicrobial Efficacy as Healthcare Personnel Handwash||BioScience Laboratories, Inc.||2013||Provodine exceeded FDA requirements for microbial kill rates of 99% within 5 minutes and 99.9% within 5 minutes after the tenth use.|
|Persistence as a Skin Preparation||BioScience Laboratories, Inc.||2009||At 6 hours, Provodine showed 14% greater persistence than Chloraprep, 39% greater persistence than Betadine (7.5% PVP-I), 10% greater persistence than Betadine (10% PVP-I) and 13% greater persistence than Hibiclens.|
|Skin Performance Study||BioScience Laboratories, Inc||2009||After 5 days, participants showed softer and smoother skin on their hands, and less dryness when using Provodine than when using Hibiclens.|
|Cumulative and Persistent Efficacy as a Scrub||BioScience Laboratories, Inc.||2009||Provodine’s antimicrobial efficacy as a surgical hand scrub was comparable to Hibiclens on Days 1 and 2, and superior to Hibiclens on Day 5.|
|Effects of the Provodine Protocol on Hospital Acquired Clostridium Difficile Infections and Employee Absenteeism||St. Catherine’s Laboure Manor||2010||The addition of the Provodine Protocol to the facility’s hand hygiene program dramatically decreased absenteeism, dramatically reduced C. diff incidence, demonstrated a return on investment (ROI) of more than 200 to 1, improved hand health during product use, and was well-tolerated by employees.|
|Toxicological Assessment of Provodine on Mucosal Substrates||CPT Labs||2013||Using MatTek system, Provodine was evaluated favorably on EpiVaginal, EpiOral, EpiGingival and EpiOcular assays.|
|Franz Cell Study on Provodine||Tioga Research Laboratories||2012||Under various conditions, Provodine exhibited modulated flux of iodine thru human cadaver tissue as compared to a standard povidone iodine comparator product.|
|Human Repeat Insult Patch Test (HRIPT)||BioScreen Testing Services, Inc.||2012||In 103 live human subjects, no identifiable sign or symptom of sensitization or irritation (contact allergy)|
Provodine White Papers
|Flammability Hazard: Alcohol-Based or Combination Preps||n/a||Eliminate alcohol-based surgical preps and replace them with Provodine, a highly efficacious and non-flammable surgical prep that does not run or pool, improving safety and avoiding medical malpractice claims.|
|Investigation on the Efficacy of Povidone-Iodine against Antiseptic-Resistant Species||2009||The strains which acquired resistance against one antiseptic showed cross-resistance to all antiseptics except for PVP-I, the active ingredient in Provodine.|